510(k) · Cleared

Cleared

Synthes (Usa) Distal Radius Plate System (DRPS)

K982732510(k) TraditionalCleared Oct 8, 199864-day reviewClass II21 CFR 888.3030

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Synthes · HRS Plate, Fixation, Bone

Cleared on Oct 8, 1998 as substantially equivalent to K962616 (Synthes (Usa), 1996) and 1 other predicate after a 64-day review. Its family tree reaches back 1 generation to 1996. 1 of the 752 devices in its family, counting itself, has a Class I recall. 749 later devices descend from it.

Decided: Oct 8, 1998
Review: 64 days
Class: Class II
Product code: HRS
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K962616 (1996). 2 ancestors in all. 749 later devices descend from it, 9 citing it directly. 1 of the 752 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 1 generation backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
This deviceK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
Descendant · cites it directly · 681 of its ownK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
Descendant · 2 generations on · 678 of its ownK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
Descendant · 3 generations on · 615 of its ownK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
Descendant · 4 generations on · 606 of its ownK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
Descendant · 5 generations on · 584 of its ownK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005

Showing 5 of 749 descendants. See all descendants

Descendants cleared per year

2002high 77 (2026) · low 1 (2002)2026

Class I recalls in this family

K211616 ExcelsiusHub11 generations on · 2021

Most influential descendants

Showing 5 of 749 · See all

K023007Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002 · cites it directly681descendants
K030198Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003 · 2 generations on678descendants
K032705Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003 · 3 generations on615descendants
K050932Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · 4 generations on606descendants
K051735Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper ExtremitySmith & Nephew, Inc. · 2005 · 5 generations on584descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K962616	Synthes Dorsal Distal Radius Plate (DDRP) System	Synthes (Usa)	1996	—
0 (this device)	K982732	Synthes (Usa) Distal Radius Plate System (DRPS)	Synthes	1998	—
+1	K023007	Distal Radius Fracture Repair System	Hand Innovations, Inc.	2002	—
+2	K030198	Hand Innovations, Inc. Distal Radius Fracture Repair System	Hand Innovations, Inc.	2003	—
+3	K032705	Distal Radius Fracture Repair System	Hand Innovations, Inc.	2003	—
+4	K050932	Distal Volar Radius Anatomical Plate System	Hand Innovations, Inc.	2005	1
+5	K051735	Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity	Smith & Nephew, Inc.	2005	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2003	2	0
2004	4	0
2005	9	0
2006	8	0
2007	4	0
2008	6	0
2009	8	0
2010	14	0
2011	17	0
2012	19	0
2013	24	0
2014	42	0
2015	38	0
2016	32	0
2017	55	0
2018	32	0
2019	41	0
2020	47	0
2021	48	1
2022	41	0
2023	51	0
2024	68	0
2025	61	0
2026	77	0

FIG. 1 — Lineage of K982732, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new HRS device

#1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K962616	Synthes Dorsal Distal Radius Plate (DDRP) System Summary page 1 …(610) 647-9700 Contact: Sheri L. Musgnung Screw, Fixation, Bone Plate, Fixation, Bone Class II, 21 CFR 888.3030; 888:3040 Synthes Dorsal Distal Radius Plate System (K962616) Synthes Ti Alloy Volar Distal Radius Plate System (K963798) The Distal Radius Plate System consists of volar and dorsal plates,…	Synthes (Usa)	1996	—
*	K963798	Synthes Titanium Alloy Volar Distal Radius Plate (TI Alloy VDRP) System Summary page 1 …, Bone Plate, Fixation, Bone Class II, 21 CFR 888.3030; 888:3040 Synthes Dorsal Distal Radius Plate System (K962616) Synthes Ti Alloy Volar Distal Radius Plate System (K963798) The Distal Radius Plate System consists of volar and dorsal plates, 2.4 mm cortex screws, and 1.8 mm threaded-head buttress pin…	Synthes (Usa)	1996	—

Also cleared against K962616: 2 other devices →

What descends from it? (749)

See all 749

9 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K023007	Distal Radius Fracture Repair System	Hand Innovations, Inc.	2002	681
K040593	Periarticular Locking Plates and Screws, 2358, 2359 Series	Zimmer, Inc.	2004	162
K102694	2.4MM VA-LCP Dorsal Distal Radius Plates	Synthes (Usa)	2010	50
K153716	GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System.	Gpc Medical, Ltd.	2016	15
K163361	ANTHEM™ Fracture System	Globus Medical, Inc.	2017	14
K142419	Mini and Micro Fragments Reconstruction System-NEOFIX	Neoortho Productos Orthopedicos S/A	2014	8
K160553	DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…	Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.	2017	0
K142579	Zimmer Periarticular Plating System	Zimmer, Inc.	2014	0
K052150	Volar Plate System	Dvo Extremity Solutions, LLC	2005	0

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 11 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

None of the 2 ancestors has a recall.
Of its descendants, K023007 (Hand Innovations, Inc., 2002) has gone furthest, with 681 descendants of its own.
2 other devices also cite its predicate K962616.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HRS

54in 2025

2007high 76 (2014) · low 35 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRS

90in 2025

2007high 144 (2022) · low 57 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HRS

1in 2025

2007high 25 (2019) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HRS

2,306in 2025

2007high 3,359 (2019) · low 311 (2008)2025

MAUDE reports naming product code HRS, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	35	63	2	339
2008	35	87	11	311
2009	47	85	3	435
2010	49	100	16	491
2011	43	88	5	773
2012	59	106	4	1,663
2013	56	89	11	2,643
2014	76	57	0	2,413
2015	56	97	7	3,095
2016	44	109	5	2,276
2017	57	122	3	2,220
2018	40	116	2	2,663
2019	46	89	25	3,359
2020	48	88	1	2,790
2021	40	87	9	2,442
2022	47	144	3	1,700
2023	40	120	1	2,049
2024	54	96	0	1,849
2025	54	90	1	2,306
2026	51	82	3	—

What is it indicated for?

Synthes Distal Radius Plate System is intended for fixation of

fractures, osteotomies, including carpal fusions involving the distal

radius applied to the volar and dorsal aspect.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K982732 · printed Nov 6, 2026

Cite this page

510(k) Report. “K982732: Synthes (Usa) Distal Radius Plate System (DRPS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982732

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026